1. In this randomized controlled trial, oral lefamulin was noninferior to oral moxifloxacin for treating community-acquired pneumonia, with regards to early clinical response at 96 hours post first dose.

2. Patients who received lefamulin reported more diarrhea and nausea than those who received moxifloxacin.

Evidence Rating Level: 1 (Excellent)

Study Rundown: The rate of microbial resistance is growing among patients suffering from community acquired bacterial pneumonia (CABP). As a result, new antibiotics are required to overcome this resistance and further help manage the outstanding safety concerns. Lefamulin, a novel pleuromutilin antibiotic, is the first of its class to be approved for enteral or parenteral use in humans. In this randomized controlled trial, a 5-day oral lefamulin course was shown to be noninferior to a 7-day oral moxifloxacin course. Both medications were reported to produce a high clinical response with respect to Pneumonia Outcomes Research Team (PORT) risk class, typical and atypical pathogens, polymicrobial infections, and demographic and baseline characteristics at 96 hours post first dose. In addition, there were similar rates of adverse events between groups, though there were more episodes of diarrhea and nausea in the lefamulin group.

The study successfully randomized a high proportion of patients with more severe forms of CABP, limited use of prior antibiotics, and demonstrated low drug and study discontinuation rates, which strengthens the trial findings. The trial is limited by its extensive exclusion criteria, which restricts the results from being applied to the general patient population with comorbid diseases.

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